Makena

Makena reduces the risk of premature birth in at-risk women who have who have delivered a baby too early (preterm) in the past. This medication is only to be used in women pregnant with one baby.

Makena Overview

Updated: March 5, 2018

Makena is a prescription hormone medication used in women who are pregnant who have delivered a baby too early (preterm) in the past. Makena is used to lower the risk of delivering a baby too early. Makena belongs to a group of drugs called progestin hormones. These work to reduce the risk of premature birth through a mechanism which is currently not yet fully understood.

This medication is available in an injectable form (in an auto-injector or a vial) to be given directly into a muscle by a healthcare provider, typically once per week. Treatment usually begins between the 16th week and 0 days of pregnancy and 20 weeks and 6 days and will be continued weekly until the 37th week (through 36 weeks, 6 days) of gestation or delivery, whichever occurs first.

Common side effects of Makena include pain, swelling, and itching at the injection site.

Makena can also cause dizziness and/or drowsiness. Do not drive or operate heavy machinery until you know how Makena affects you.

Makena Interactions

No drug interactions have been conducted by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Makena Precautions

Serious side effects have been reported with Makena including the following:

Blood Clots. Tell your doctor immediately if you experience any of the following:

Leg swelling

Redness in your leg

A spot on your leg that is warm to touch

Leg pain that worsens when you bend your foot

Allergic reactions. Severe and potentially life-threatening allergic reactions are possible during treatment with Makena. Get emergency medical attention immediately if you develop any of the following symptoms of a severe allergic reaction:

sudden difficulty breathing

sudden and abnormal swelling of the face, lips, tongue, and/or throat

hives

sudden development of a red blister-like skin rash

sudden drop in blood pressure

Depression. Tell your doctor immediately if you notice a change in your mood.

Reduced glucose tolerance. Makena can reduce your body's ability to tolerate large amounts of glucose. Be sure to inform your physician if you have diabetes or prediabetes, as this can affect how your body responds to this medication.

Jaundice. Tell your doctor immediately if you notice yellowing of your skin and the whites of your eyes.

Makena can also cause dizziness and/or drowsiness. Do not drive or operate heavy machinery until you know how Makena affects you.

Do not take Makena if you:

are allergic to Makena or to any of its ingredients

have or suspect you may have breast cancer or any other hormone-sensitive cancers

have unusual vaginal bleeding due to an unknown cause

have a medical condition called cholestatic jaundice of pregnancy (yellowing of your skin due to liver problems during your pregnancy)

have liver tumors or any active liver disease

have untreated high blood pressure

have or have a history of blood clots

Makena Food Interactions

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Makena, there are no specific foods that you must exclude from your diet when receiving this medication.

Makena and Pregnancy

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Makena falls into category B. Makena has been given to women in their second and third trimesters and did not result in harm to the baby. In animal studies, pregnant animals were given this medication and the babies did not show any medical issues related to this medication.

Makena is not intended for use in the first trimester. Treatment usually begins between the 16th week and 0 days of pregnancy and 20 weeks and 6 days and will be continued weekly until the 37th week (through 36 weeks, 6 days) of gestation or delivery, whichever occurs first.

Makena and Lactation

You will likely discontinue Makena at 37 weeks of pregnancy or upon delivery. Detectable amounts of progestins have been identified in the milk of mothers receiving progestins. Many studies have found no adverse effects of medications similar to Makena on breastfeeding performance, or on the health, growth, or development of the infant.

Makena Usage

Makena comes in an injectable form to be given directly into a muscle by a healthcare provider, typically once per week.

Treatment usually begins between the 16th week and 0 days of pregnancy and 20 weeks and 6 days and will be continued weekly until the 37th week (through 36 weeks, 6 days) of gestation or delivery, whichever occurs first.

You will receive this injection in a clinic or doctor's office. Your doctor will need to check your progress on a regular basis while you are using this medication.

It is very important that you do not miss a dose of Makena and that you continue to receive the medicine once a week. If you miss a dose, talk to your healthcare provider for specific directions on how to get back on schedule.

Makena Dosage

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended dose of Makena (auto-injector) is 275 mg administered once weekly in the back of either arm.

The recommended dose of Makena (vial) is 250 mg administered once weekly into the upper, outer area of the buttock.

Treatment usually begins between the 16th week and 0 days of pregnancy and 20 weeks and 6 days and will be continued weekly until the 37th week (through 36 weeks, 6 days) of gestation or delivery, whichever occurs first.

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